Clinical trial · Interventional
Cyclosporine in Treating Patients With Recurrent or Refractory Angioimmunoblastic T-Cell Lymphoma
A Phase II Study of Cyclosporine in the Treatment of Angioimmunoblastic T-Cell Lymphoma
NCT00070291CI-TRIAL-00067652terminatedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Slow accrual.
Summary
Brief summary (as posted)
RATIONALE: Cyclosporine may help the immune system slow the growth of angioimmunoblastic T-cell lymphoma. PURPOSE: This phase II trial is studying how well cyclosporine works in treating patients with recurrent or refractory angioimmunoblastic T-cell lymphoma.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cyclosporine | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cyclosporine
- description
- High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment.
- interventionNames
- Drug: cyclosporine
Primary outcomes (1)
- measure
- Response Rate (Complete and Partial Response)
- timeFrame
- Assessed at weeks 6, 12, 24 and 36 from onset of treatment, and then at 1 year, 18 months, 2 years and 3 years from registration during follow-up.
- description
- Response was assessed based upon the criteria from the International Workshop to Standardize Criteria for Non-Hodgkin's Lymphoma. Response included complete response and partial response. Complete response was defined as complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease related B-symptoms if present prior to therapy, as well as normalization of those biochemical abnormalities definitely attributed to NHL. All lymph nodes and nodal masses must have regressed to normal size. Partial response was defined as a decrease of \> 50% in the SPD (sum of the products of the diameters) of the six largest (or less) dominant nodes or nodal masses, no increase in the size of the liver or the spleen, and no new sites of disease.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of angioimmunoblastic T-cell lymphoma (recurrent or refractory) based on histologic examination. * At least one objective measurable or evaluable disease parameter. * Have failed at least one type of treatment: chemotherapy, auto-transplant, or steroid treatment. Patients may not receive concurrent chemotherapy. * Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. * Adequate renal function as indicated by creatinine \<= 1.5 the upper limit of normal (ULN). * Adequate liver function as indicated by alkaline phosphatase, Aspartate Aminotransferase (AST), and Alanine Aminotransferase (ALT) \<= 2x the upper limit of normal. * Total bilirubin \<= 2x the upper limit of normal. * Age 18 or older. Exclusion Criteria: * Prior cyclosporine or Tacrolimus (FK506). * Prior allogeneic transplant. * Evidence of active infection. * Congestive heart failure, kidney failure, liver failure, or other severe co-morbidities. * Evidence of active neurological impairment. * Previous history of hypersensitivity to cyclosporine and/or Cremorphor EL (polyoxyethylated oil). * History of other malignancies (other than cured carcinomas in situ of the cervix or basal cell carcinoma of the skin). * pregnant or breastfeeding women. * Human immunodeficiency virus (HIV) positive.
References
Publications (0)
Data not yet available
No reference posted for this study.